FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71335-0606
11-digit product format
713350606
Labeler code
71335
Product ID
71335-0606_ec7168d7-0393-4b83-96bb-f33fe04889a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0606-1Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED30103
71335-0606-2Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED90103
71335-0606-3Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED60103
71335-0606-4Rosuvastatin120 in 1 BOTTLETABLET, FILM COATED120103
71335-0606-5Rosuvastatin180 in 1 BOTTLETABLET, FILM COATED180103
71335-0606-6Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0606-1EA - Each71335-0606ca137c59-b30e-4f09-be08-4380c89811be12018-03-08
71335-0606-2EA - Each71335-0606dd73ff8e-728c-4e02-84aa-e341f1a72b2812018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0606ROSUVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20241113_aa7443b0-9f75-47fc-a5ce-c7245444419c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNaa7443b0-9f75-47fc-a5ce-c7245444419c103
859747rosuvastatin calcium 10 MG Oral TabletSCDaa7443b0-9f75-47fc-a5ce-c7245444419c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0606-17133506060130 TABLET, FILM COATED in 1 BOTTLE (71335-0606-1) 2018-02-090000-00-00NoNoCurrent
71335-0606-27133506060290 TABLET, FILM COATED in 1 BOTTLE (71335-0606-2) 2018-06-220000-00-00NoNoCurrent
71335-0606-37133506060360 TABLET, FILM COATED in 1 BOTTLE (71335-0606-3) 2024-10-300000-00-00NoNoCurrent
71335-0606-471335060604120 TABLET, FILM COATED in 1 BOTTLE (71335-0606-4) 2024-10-300000-00-00NoNoCurrent
71335-0606-571335060605180 TABLET, FILM COATED in 1 BOTTLE (71335-0606-5) 2024-10-300000-00-00NoNoCurrent
71335-0606-671335060606100 TABLET, FILM COATED in 1 BOTTLE (71335-0606-6) 2024-10-30NoNoHistorical